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Xolegel

Drug Description
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XOLEGEL
(ketoconazole) USP Gel, 2%

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DRUG DESCRIPTION

XOLEGEL Gel contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle.

Chemically ketoconazole is (±)-cis-l-Acetyl-4-[p-[[2-(254-dichlorophenyl)-2-(lH-imidazol-l-ylmethyl)-l,3-dioxolan-4-yl] methoxy]phenyl] piperazine, with a molecular weight of 531.43.

Figure 1

Each gram contains: 20 mg ketoconazole USP, 34% dehydrated alcohol USP, ascorbic acid USP, butylated hydroxytoluene NF, citric acid monohydrate USP, glycerin USP, hydroxypropyl cellulose NF, polyethylene glycol 400 NF, PPG-15 stearyl ether, propylene glycol USP, FD&C yellow No. 6, D&C yellow No. 10

XOLEGEL Gel is a smooth, translucent to clear, amber gel.

Brand Name: Xolegel
Generic Name: Ketoconazole
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